Multiple Myeloma and the MMRF CoMMpass Study: Revolutionizing Clinical Trial Data Dissemination A Panel Discussion With the Researchers

Interview with the Innovators

The Multiple Myeloma Research Foundation (MMRF) launched the CoMMpass study in 2011 to uncover the molecular segments and variations in multiple myeloma. This study, the cornerstone of the larger MMRF Personalized Medicine Initiative, is designed to profile multiple myeloma in a way that no other myeloma trial has attempted, by comprehensively characterizing the disease in over 1000 newly diagnosed patients and obtaining their clinical and genomic information at an unprecedented level of detail from initial diagnosis through the course of at least 15 years. With this effort, the hope is to find the Achilles’ heel of multiple myeloma in order to accelerate both the science and the testing of new therapeutic approaches to achieve a cure for this disease. The goals of the study include:

• Targeting of existing therapies. Patients with different genetic markers are known to react more positively to some therapies than others. The aim is to create a guide to which treatments work best for specific patients, allowing doctors to select the most effective treatment for each patient
  
• Personalized treatments. Genetically targeted treatments may offer the best hope for treating and curing multiple myeloma. The MMRF CoMMpass study will give researchers access to data and insights that will help them design the next generation of multiple myeloma treatments targeted toward patients with specific genetic markers

A notable detail of this trial is that the data collected will be made available via the world’s first and only open access data platform in myeloma. The MMRF launched 2 of these first-of-their-kind open access gateways – one for researchers and one for patients – that will facilitate data sharing and accelerate drug development and cancer research. The MMRF Researcher Gateway will upload comprehensive genomic data and clinical data from the CoMMpass study and other global data sets and make them accessible to all scientists, with the goal of speeding up the development of precision therapies and ultimately advancing cures. The MMRF CoMMunity Gateway will aggregate subtypes of myeloma patients and steer them to treatments and trials that are specific to their profile.

The staff of Personalized Medicine in Oncology had the pleasure of working with Walter M. Capone, Chief Operating Officer of the MMRF, to conduct a panel discussion with the researchers and clinicians who have helped to initiate the CoMMpass study; Dr Sundar Jagannath of the Mount Sinai School of Medicine; Dr Sagar Lonial (principal investigator of the CoMMpass study) of Winship Cancer Institute of Emory University; and Dr Gregory Orloff of Virginia Cancer Specialists. To view the interview in its entirety, please go to www.PersonalizedMedOnc.com/videolibrary.

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Walter M. Capone is Chief Operating Officer of the MMRF.

Sundar Jagannath, MD, is Director of the Multiple Myeloma Program and Professor of Medicine at The Tisch Cancer Institute, Mount Sinai School of Medicine. He is an Investigator for the MMRF CoMMpass study.

Sagar Lonial, MD, is an Associate Professor at the Winship Cancer Institute of Emory University, Director of Translational Research, B-Cell Malignancy Program as well as Associate Director of Hematology Oncology Fellowship Program. He is Principal Investigator of the MMRF CoMMpass study.

Gregory Orloff, MD, is a Medical Oncologist at Virginia Cancer Specialists. He is an Investigator for the MMRF CoMMpass study.

Mr Capone I would like to begin our discussion by asking each of you to define precision medicine in your own words, particularly as it relates to the treatment of patients with multiple myeloma. Dr Orloff, would you mind offering the first perspective?

Dr Orloff I would define personalized medicine in a number of different ways. It is the molecular profiling of individuals to better stratify their risk, to study the molecular story of multiple myeloma, and to find new drug targets.

At the same time, as a clinician, personalized medicine is the individual’s assessment of a patient. Sometimes the patient may have comorbidities that would lead us to choose a drug therapy that would be different than for another individual.

Dr Jagannath I agree with your statement, Dr Orloff. We always try to take each patient as they come with their clinical presentation as well as their disease characteristics.

We are trying to understand the disease biology in greater depth. Personalizing medicine is important because multiple myeloma is not a single genetic disorder, and so there are multiple abnormalities happening. Even in a single patient there are a number of clones of myeloma, and at any particular time there is a driver mutation that causes clinical manifestation of the disease. Then we treat the disease and it goes into remission, but not all the clones are being eradicated. Once we understand in greater depth through the CoMMpass trial what the driver mutation is, we can decide how to approach it.

Mr Capone Thank you very much, Dr Jagannath. Dr Lonial, your perspective?

Dr Lonial In many other cancers when we think about driver mutations, we think about a single abnormality. When you block that abnormality, the disease responds tremendously. And in many of those diseases – such as lung cancer or breast cancer – they don’t have great therapies outside of those single driver mutation tumors.

In myeloma we’re fortunate. If you take a proteasome inhibitor and an IMiD and a steroid, almost everybody will respond, but the durability of that response is what’s so different, and that’s where the individual mutation states and the differences in genetic heterogeneity really present themselves. So in my mind, using CoMMpass will help us to build on what we already have as a good platform – proteasome inhibitors, IMiDs, corticosteroids – and put in that fourth drug potentially, whether in sequence or in combination, that helps get to that Achilles’ heel.

Defining Goals of the CoMMpass Trial

Mr Capone Dr Lonial, could you give your perspectives as the principal investigator for the CoMMpass trial and what you see as perhaps the most important goal in the trial?

Dr Lonial I think there are lots of large trials being done around the world in which patients all get uniform therapy throughout the entire course of a given protocol. What CoMMpass allows us to do is get real-world experience with patients who are treated in everybody’s clinic, not just patients who fit these very selective clinical trial enrollment criteria. Basically to enroll, you have to have myeloma. It’s really pretty simple.

Then it allows us to get that nice diversity of treatment approaches with the genetics and long-term follow-up so that we can really sit down with patients and say, “there are 40 or so patients who had exactly what you have and were treated just like you were in this clinical experience, and this is what happened to them.” So I find the heterogeneity of the treatments to be helpful in trying to tailor treatments to patients.

Dr Orloff I have a comment that’s a bit sobering. The great advances we’ve made in the last 10 years for the majority of patients – nearly doubling survival – unfortunately haven’t had significant impact in that subset of patients we define as high-risk based on our current methodology for stratifying patients at the time of their diagnosis, even at the molecular level. And I think perhaps a significant goal of the CoMMpass trial will be to identify new targets and therapies for that subset of patients we have unfortunately been unable to affect.

Dr Jagannath I completely agree with both of you. We need new targets, especially for high-risk myeloma patients. But in general practice it’s good to know that patients are treated in different places in different ways, but their outcomes are more or less similar, because we have information from individual clinical trials on patients who are treated uniformly, and their outcomes. Before CoMMpass, we’ve never had a prospective way to say this particular subset of patients do poorly or do well with these treatment approaches.

Mr Capone That’s very helpful to understand just what differentiates CoMMpass from efforts that have gone on before. The heterogeneity of multiple myeloma makes it very complex in terms of defining and pursuing treatment approaches. Could you please give us your perspectives about how the MMRF CoMMpass study will help to more accurately link outcomes to genetic profiles.

Dr Jagannath The main purpose of the CoMMpass trial is not only do the deep sequencing and know the biology of the disease; it is also tied to the clinical outcome of the patient, so you’re going to be able to put both of them together – how the patient fared on the treatment and how the disease presented in that particular patient.

Dr Orloff I think the CoMMpass trial has already in its interim analyses uncovered the extraordinary heterogeneity of this disease. For many years we thought that all cancers were due to just 1 cell transforming, growing, and proliferating abnormally. We’ve come to understand through much of the cancer research that that is not the case.

And as has been uncovered in the first of the interim analyses, there are subclones of this disease that remain permanently in patients, unfortunately leading to the incurability of the disease. It is the study of those subclones that will be paramount.

Dr Lonial Heterogeneity is clinically challenging as well as biologically challenging. I think we’ve all had patients who were sitting next to other patients in the waiting room and said, “You know, I was on drug X and it worked for me for 5 years. Why didn’t it work for the person who was sitting next to me?”

With the longitudinal follow-up of patients in the CoMMpass study, we’re able to look at genetics. We’ll be able to not just analyze how patients did in a clinical trial based on whether they received regimen A versus B, we’ll be able to individualize the treatment, recognize the genetic differences, and observe the outcomes, which no trial to date has really been able to do.

Dr Orloff Dr Lonial, I think your analogy of the waiting room is correct. We all see patients whose workup and stratification based on our current methodology would be considered equivalent, but their outcomes are clearly distinctly different.
Implications of International Involvement in the CoMMpass Trial

Mr Capone Dr Lonial, the MMRF CoMMpass study is on the verge of becoming international. We’ve just started enrolling new sites and new centers in Canada, and soon we will be opening sites in Europe as well. Can you provide your perspective on how international sites and patients in the study will have an impact on the data?

Dr Lonial I think it’s a real opportunity for us. Myeloma investigators and clinicians have really enjoyed the global approach to myeloma drug development. We may have done some of the early trials in the United States, but the large phase 3 trials are usually done around the world with our European and Asian partners.

To be able to include our European and Canadian colleagues in this kind of a trial is important because it does build that larger team. I think it also adds some level of genetic diversity, to be honest with you, and knowing that it’s a heterogeneous disease, genetic diversity helps us to better understand the drivers and how to treat myeloma overall.

Dr Jagannath I think that one of the strengths of the CoMMpass trial is that it is not a defined treatment protocol. You are able to incorporate not only multiple sites in the United States but in Canada and Europe as well and still fulfill the objective of the CoMMpass trial; that is, no matter how you are treated and where you are treated, we would like to know what the outcomes and challenges are. It also gives us a better perspective about certain subtypes.

The Europeans and the Canadians don’t treat exactly like the Americans. That by itself will be fundamentally important. I think that’s the beauty and the strength of the CoMMpass trial compared with an individualized, single-institution trial or a single cooperative group trial.

Dr Orloff I think even beyond the science component of the heterogeneity of our populations is what we’re launching today – the new platform through the Web in order that researchers everywhere will be able to use this information. And even if the CoMMpass trial remained as an undertaking just in North America, that endeavor would still be fulfilled, but I think this will allow scientists and researchers around the world to embrace it to a much greater extent and in fact utilize intellectual property to the betterment of all.

Dr Lonial And from the patient perspective, if you’ve got people from both sides of the ocean banding together to say, “We all have the same abnormalities, where are the trials,” I think it does bring the community, both the treating side and the patient side, closer.

Dr Orloff In that respect, build the critical mass, so we need to truly accelerate the scientific and therapeutic advances we’re all striving for.
Advancing Therapeutic Approaches to Cancer

Mr Capone Dr Orloff, I’d like to ask you how you believe the CoMMpass trial might help impact and perhaps enhance the development of new therapeutic approaches for different tumor types.

Dr Orloff I would want to begin by saying the launch today of the research gateway is probably the greatest component that will lead to the molecular understanding of this disease and allow for this information to be parlayed into the research undertaken all over the world studying other malignancies. And I have no doubt that by the careful profiling of more than 1000 patients worldwide and the ability of researchers everywhere to utilize this information, this information will spill over to better the outcomes for patients with other malignancies.

Dr Jagannath This is a wonderful opportunity, as we saw when the MMRF published an original study in Nature in which BRAF mutations were identified in 5% of multiple myeloma patients. We already knew BRAF was a very important mutation in melanoma, and there is a drug being used there. My feeling is there will be common pathways and driver mutations that are shared across cancers, so the drug that is being developed in one disease could be repositioned in other diseases. And likewise, as you understand the pathway of the driver mutation in one disease, it will immediately facilitate the understanding of the other diseases. There will be a lot of give and take because of the heterogeneity of myeloma. This is why patients have to be sequenced in deep sequencing and followed.

Dr Lonial I think a great example of that is the MMGI [Multiple Myeloma Genomics Initiative] in which KRAS and NRAS were identified as very common abnormalities and mutations seen in a small subset of patients.

The lung cancer and the colon cancer researchers were all over NRAS and KRAS because it’s pretty significant for their outcomes as well. We’re all playing on the same team. We all want to target KRAS and NRAS, and in fact, KRAS and NRAS may have an impact on our own existing therapies. There may be certain subsets that are more or less likely to respond based on KRAS or NRAS. NF-?B is another one. There are mutations, and then you have NF-?B pathways that are really relevant for lymphomas.

I think if we can identify those common mutations, it’s not just our team working against them, it’s a larger group of people that helps us to attack cancer globally.

Mr Capone It really does reemphasize the underlying biological basis and the shared connection that we have with many other types of cancer.

Dr Lonial, how do you believe the CoMMpass trial data will help to inform and standardize, perhaps improve, laboratory testing for molecular biomarkers and the development of companion diagnostics for myeloma therapies?

Dr Lonial I think one of the things that we have done in myeloma therapy is to treat patients with myeloma in somewhat of a homogenous way.

What I think CoMMpass will allow us to do is to look at the patient’s treatment regimen and their genetic profile to see if their mutations have predicted for responses. If they did, those become biomarkers. Biomarkers may not be as important in the induction therapy setting, but they may be really important in the maintenance setting.

If you know that people with certain mutations are more likely to respond to an IMiD in the maintenance setting, you’re almost always going to treat them with an IMiD as maintenance therapy.

I think as these get more and more defined, we will start to identify the predictors of response or lack of
response.

Dr Orloff I might extend upon your comment that biomarkers may be very helpful in determining a more ideal second-line therapy, Dr Lonial, to push it a little earlier in the course of therapies. While we don’t have an enormous portfolio of choices at this time, I think we are all quite confident there will be new drugs and new families of drugs available within a short period, and we’ll be better able to understand what would be the better strategy for second- and third-line therapy.

Dr Jagannath Dr Orloff, you spoke earlier about the high-risk patients in whom we really need to make progress. Now we may actually find out that there are not just low-risk and high-risk patients, there are multiple subsets of patients, and as new drugs come out for different driver mutations, even how we may treat these patients may change over a period of time. They may not all be starting with the proteasome inhibitor, and IMiD modular molecular, etc. We started out with the term “personalized medicine.” It may come to fruition that we may understand that these patients could be handled differently at the different phases of the disease. I think this is an important discovery.

Mr Capone Longitudinal follow-up really is key to be able to do that, because what you’re going to see are patients who present with a certain profile at diagnosis. They receive a certain treatment, and when they relapse, if unfortunately they do relapse, we’ll see what that profile has changed to as a consequence of original mutations and treatment, and that will help us to select a second, third, and fourth line to try and avoid those kinds of problems.

Dr Orloff I think what we just said is so important. This is a discovery. We’re looking for new answers.

Open Access Through the MMRF Researcher Gateway

Mr Capone Being able to map and anticipate and create as long as possible pathways for patients to achieve durable remissions clearly will be aided by this type of approach.

Certainly, obtaining all the comprehensive information over an extended period as we’ve talked about – clinical, genomic, and the full profile of disease – will be critically important and an elemental step of the MMRF CoMMpass study.

Could you describe what the significance of providing that kind of information openly to researchers around the world would be? What goal would you like to see coming from that type of approach? Also, what is the significance of the MMRF Researcher Gateway, the approach by which many researchers will be able to access this information? Dr Orloff, would you start with the idea of making this kind of data open and available to researchers worldwide?

Dr Orloff Intellectual property is certainly an issue in the development of all strategies to care for patients throughout medicine. By providing this information to the entire world – to all researchers – we’re in fact breaking down the barriers regarding intellectual property.

Dr Jagannath It’s a change in paradigm approach.

Dr Orloff Exactly.

Dr Jagannath That’s important. Researchers have different interests and certain patterns of thinking about their particular research. By making our database universally available, researchers who are working on something completely different can access the myeloma database and make observations that sometimes even the people working in the field may not have picked up. This is a quantum leap. To me this is really a major advance in the way we want to move the field.

Dr Lonial I think that’s absolutely right. I think there are data that ultimately do get put on portals for availability, but that’s often years after the data have been acquired and somebody else has had a chance to get the first evaluation and publication on those data. Once that occurs, then the data are put up on a public site. This is going out from the get-go. Giving everybody access to the information and knowledge is incredibly powerful and creates a bigger team. People all over the world are going to have access to the genetics and genomics with longitudinal follow-up. Patients are going to be able to partner better with institutions to say, “This is what I have, how can you help me?”

Dr Jagannath I think the strength of allowing Canadians and Europeans to participate, in addition to rapid accrual, is that you are actually bringing international investigators to the table so to speak. That in itself is important.

Mr Capone That supports the effort to really unite and create that critical mass and also create the methods by which we can actively share the information and the insights, as you described, which might have no direct connection or application to myeloma. And, Dr Jagannath, I also recall that you viewed the MMRF Researcher Gateway in a certain context as leveling the playing field among different types of institutions and the investigators and researchers regardless of their vantage point of the disease. So thank you very much for that perspective.

Thank you, because really what you have just described was one of the fundamental premises of establishing the MMRF Researcher Gateway, which was really an effort to unite many different types of researchers and research centers and the ability to not only analyze but share the data that they’re deriving and, as Dr Jagannath has said in a previous context, level the playing field among centers so that everyone can benefit and accelerate their own individual discoveries and benefit from the work that other centers are doing at the same time.

Dr Lonial, I’d like to ask you, from the data that have been released on the CoMMpass study so far, what conclusions or observations would you offer?

Dr Lonial I think what we’ve seen already in the first patients who have been enrolled is that there is a tremendous variation among what different patients are receiving, and that diversity of treatment will be tracked over time so we can look at outcomes based on the individualized treatment approaches.

From the genomics perspective, which is the other real gold mine in the trial, what we’ve already seen in the first patients who have been sequenced is validation of some of the discoveries that were presented in the original MMGI that was published in Nature. What we don’t have from the MMGI is tracking as to what that meant and identifying what therapy patients received that led to that clinical outcome.

So those 2 pieces of information really are why this trial is going to be even more important than what we learned from the early studies of sequencing.

Dr Orloff When we were first putting together the trial, we wrestled with what would be first-line therapies for patients. While initially there was some debate and thought that it should be just 1 single course of treatment, in fact a 3-drug regimen was what many favored, as there was agreement within the MMRC [Multiple Myeloma Research Consortium] that it was necessary to offer the opportunity for physicians to personalize the approach to the care of their patients based on their needs. And for that very reason, the data now are probably a bit confusing but are going to be very helpful in long-term follow-up.

Dr Jagannath The strength of this whole CoMMpass trial is allowing the physicians to treat in the community the way they would like to treat the patients. We don’t dictate how they should be treated, but we will collect all the information, and thereby the data become robust so we can actually answer all these important questions for the future.

Mr Capone Dr Jagannath, I’d like to ask how you would expect to utilize the data from the MMRF CoMM­pass trial to help guide treatment decisions in your patients.

Dr Jagannath The CoMMpass trial is really a paradigm shift. Here, as the patients are accrued, the data are made available in real time through the portal for investigators. They are not sequestered. They won’t be analyzed at the end of 2 years and somebody’s going to present them. You can actually know what is happening.

In the meantime, there are other investigators, other clinical trials that are releasing information. There are KRAS and NRAS mutations as Dr Lonial alluded to, and there are drugs in clinical trials. I hear that one of the patients whose disease was progressing was given this inhibitor for the RAS mutation, and the patient went into remission. We’ve also heard about a BRAF mutation in Germany. One of the patients received a medication for the BRAF mutation, and his myeloma went into remission.

I would be getting all this information in real time, so when my patient’s disease comes back, I can go back into the database and find out about other patients with this particular genetic feature. So this really is a remarkable opportunity.

Dr Orloff I do want to make one cautionary statement. In the field of clinical medicine and oncology we do believe in evidence-based approaches, and those are the approaches to deciding what would be the best therapy for the individual and the aggregate. And a little caution to say that a single individual’s outcome utilizing an agent because they had a specific molecular profile could benefit the larger population, it still remains a question.

Dr Lonial Regarding the BRAF mutation, I think we’re all excited that we have drugs on the shelf that we can use, but we don’t know the natural history of BRAF from diagnosis. So to be able to get a collection of 50 patients who had BRAF mutations at the time of diagnosis and see what happened with treatment X is very exciting. We’ve heard the great stories from Germany and from the UK in the refractory/relapsed setting where there was nothing else left to do, and that drug really made a big difference, but it may do just as well from the beginning for people who are BRAF negative. That to me is an incredibly exciting opportunity to learn about the natural history of these mutations from diagnosis.

Dr Jagannath I completely agree. I also understand evidence-based medicine is important. What I want to convey is the palpable excitement that I feel in having something like CoMMpass rolled out to a large number of patients and in what it could do by making the information available in real time. It also excites the pharmaceutical industry. They may have a drug with 1 indication. But where else can they move with this molecule? So that makes them excited because this information is made available to them too.

I think it is multiple combinations. But I completely agree, we are to be cautious, and evidence-based medicine is very important.

Mr Capone I’d say the one aspect that perhaps really distinguishes or differentiates the initiatives that we’re all embarking on with the MMRF CoMMpass trial is that the strength of having so many centers – over 50 in the United States, over a dozen across Canada, and about an equal number eventually in Europe – is the ability to move from one approach or interpretation, like you just mentioned, Dr Orloff, to one in which we’re actually rapidly bringing together numbers of patients with a similar profile to assess and determine: is this real? is this signal actually happening? and is that outcome replicable or not? That is really helping to advance the science at a much more rapid pace.

And the infrastructure that you’ve all helped to create and the vision that you had from the very outset has enabled that platform to go forward. So in this way hopefully we’ll move forward that much faster.

Dr Orloff I heard the CEO of the MMRF used the phrase “big science,” and that’s really what the goal is here too. Larger numbers will reveal answers more quickly.

Shaping the Future of Clinical Trials

Mr Capone Dr Lonial, I’d like to ask if a chromosomal abnormality or biomarker is detected in the MMRF CoMMpass trial, how do you think this would be tested in future clinical trials through the CoMMpass network and perhaps involving patients from the trial?

Dr Lonial I think a lot of what we’re going to be seeing in terms of the small data sets that come out of that giant, 1000-patient database are hypothesis-generating ideas. So we see somebody that has, let’s just take something simple, p53 deletion, 17p. We see that occurring. We see the outcomes, we see the other genetic abnormalities that are associated with patients with p53. Not all p53 deletions are the same. There are patients who do better, there are patients who do worse, and we can look at those individual components and enroll them on a trial within the MMRC or other large trial sets, and patients will know, “I have this mutation. Is there a trial somewhere that focuses just on this mutation?”

And that concept is exciting because it really does take it out of just the individual investigator’s hands. We all like to enroll patients, suitable patients for suitable trials, but it also gives the patients who may not live in that city the opportunity to say, “This is what I have, and if I go to this place 2½ hours away I can get this drug that may target specifically what I have.” And those kinds of small hypotheses that we generate from the CoMMpass trial will, I think, be useful in helping to fuel faster enrollment to those targeted trials.

Dr Jagannath Regarding the findings in the CoMM-pass trial, we are making them available globally, and others are also doing clinical trials, and they would have access to them. So the hypothesis-generation testing becomes universally available, and people can decide which needs to be tested right away for which new drugs that are available. So that will also help shape how progress is made.

I think this opens up many opportunities. We cannot necessarily predict the future, but this is a good beginning, and it’s very important for the field.

Mr Capone To make these kinds of trials happen for targeted therapeutics, a large network that connects patients and researchers working together more actively will help enable this progression much more quickly.

As we bring this discussion about the MMRF CoMM­pass clinical trial to a close, I’d like to ask you for your perspectives on the future prospects for this kind of groundbreaking initiative and in one sense how we can ensure, whether through education or other initiatives, that the broader oncology community is able to benefit from the findings and the science that is being generated.

Dr Orloff I’ll begin by saying I think this is an enormous task of the MMRF and the MMRC. This is an unprecedented study. There is no doubt that in the years to follow we’re going to find new drug targets, develop new agents, and improve survival of individuals with this disease. It’s incumbent upon the MMRF to find ways to bring this information to the larger community, a very difficult task.

Dr Jagannath I agree with that. This is really a groundbreaking advance and a way to bring all the physicians and patients together. What I mean by that is you’re going to collect all these deep secrets, information on all these patients, and the clinical information is tied to the data, so the data are extremely valuable, and you are making these data available in real time to the physicians and the patients who are participating in the clinical trial, for their benefit, but also to the wider community of investigators, and to the pharmaceutical industry. So I’m pretty sure everybody will be watching for the success of this particular program, and if it is successful, and it makes rapid transformation in the treatment and finding a cure for myeloma, I’m pretty sure this paradigm will be readily adopted by others.

So I think this has great potential in many ways. It is groundbreaking. It levels the playing field because the information is made available to everyone at the same time, in real time. That has never been done so far.

Dr Lonial I think one of the things we struggle with as a myeloma community is that if you ask 5 different myeloma doctors how to treat a given patient, you’ll get 7 different answers because there’s no clear-cut standard way to approach patients. We debate regimen A versus regimen B, and there’s a lot of confusion in the world about what the best regimen or treatment is because we’re trying to look at a small subset of patients here or there and are not able to answer the question.

What I think CoMMpass will allow us to do is to get a large enough data set with clinical heterogeneity, lots of patients, genetic heterogeneity, lots of different types of patients, and treatment heterogeneity so that you could then go back and say well, if you have a 414 with this mutation, and you got a 3-drug regimen, your outcome was actually really very good. That could be incredibly valuable for the oncologists to help decide how to navigate through this menu of 8 different regimens to choose the one that he or she thinks is going to be the best for the patient. Disseminating that information is really important.

Dr Orloff And I think there are guidelines and there are pathways for the treatment of patients with the different malignancies. Myeloma has a pathway, but it’s really a bit complicated at this point, and what we’re really going to be able to do is build a more careful pathway for people, both physicians in academic centers and within the community, to follow along in the treatment of their patients.

Mr Capone I’d like to thank each of you for your time this afternoon and for your very helpful and insightful perspectives about the MMRF CoMMpass trial, the MMRF Researcher Gateway, and the MMRF CoMMunity Gateway, and how this entire effort is intended to help accelerate the advancement of our understanding of this disease and accelerate the assessment and rapid progression of new therapeutic approaches to help extend and improve the lives of myeloma patients.

I’d just like to close by recognizing your individual contributions to help making this program a success so far and to creating such great promise and vision for it.

Dr Orloff, you actually enrolled the first CoMMpass patient back in July 2011. Getting the trial up and running was really through Virginia Cancer Specialists, so we can’t thank you enough for that effort.

Dr Jagannath, yours was the first academic institution along with Washington University Medical Center to sign on to the CoMMpass trial, to understand what we were trying to do, to convey information to the public rapidly to advance the science dramatically, and you’re also the leading enrolling center in CoMMpass right now.

Dr Lonial, you have stood with us along with Drs Orloff and Jagannath to help design the studies from the outset, and you are the pioneer who agreed to sign on for this mission for the duration of time that we have, up to 10 years, so with your vision and your inspiration collectively this will be an unprecedented success.

My thanks to you all.

For more information about the MMRF Personalized Medicine Initiative and the CoMMpass trial, please contact MMRF, 383 Main Avenue, 5th Floor, Norwalk, CT 06851. Phone: (203) 229-0464. E-mail: info@themmrf.org. www.them mrf.org

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